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Non-invasive Brain Stimulation
tDCS + TUS for Opioid Use Disorder
N/A
Recruiting
Led By Ciro R Estebanez, MD PhD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 to 85 years old.
Suffering from severe depression (with a score of >30 in the Beck Depression Inventory (BDI), PHQ-9≥10).
Timeline
Screening 1 day
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial will study whether transcranial Direct Current Stimulation (tDCS) + Transcranial Ultrasound (TUS) can help treat addiction in people with chronic pain who use opiates. The investigators think active stimulation will be better than fake stimulation.
Who is the study for?
This trial is for adults aged 18-85 with opioid use disorder (OUD) and chronic pain, who have been diagnosed according to DSM-5 criteria. Participants must consent to the study, live locally without relocation plans, and can't be on high doses of methadone. Excluded are pregnant individuals, those with a history of illegal stimulant use or certain neurological disorders, recent brain surgery patients, or those on new antiepileptic drugs.Check my eligibility
What is being tested?
The study tests if transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) helps treat addiction in people with OUD and chronic pain. It compares active stimulation's effects on drug use reduction and psychosocial improvement against sham (fake) treatments.See study design
What are the potential side effects?
While not explicitly listed in the provided information, tDCS and TUS may cause mild side effects such as headache, scalp discomfort at the site of electrode application for tDCS; TUS might include local discomfort or skin irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
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I have severe depression based on standard tests.
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I currently have cancer.
Timeline
Screening ~ 1 day1 visit
Treatment ~ Varies
Follow Up ~ 24 weeks9 visits
Screening ~ 1 day
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in drug use from baseline.
Secondary outcome measures
15-item Barrett Impulsivity scale
Changes in pain as measured by the Visual Analog Scale (VAS)
Changes in the Verbal Rating Scale (VRS) for Pain
+13 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active (tDCS) + Active TUSActive Control1 Intervention
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)
Group II: Sham (tDCS) + Sham TUSPlacebo Group1 Intervention
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Highland Instruments, Inc.Industry Sponsor
10 Previous Clinical Trials
523 Total Patients Enrolled
Case Western Reserve UniversityLead Sponsor
299 Previous Clinical Trials
246,552 Total Patients Enrolled
Ciro R Estebanez, MD PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center/ Case Western Reserve University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had fainting spells that doctors couldn't explain.I have not consumed poppy seeds or herbal teas that could affect drug tests.I have had a head injury that caused me to lose consciousness.I have a history of stroke, brain tumors, or epilepsy.I have severe depression based on standard tests.I am between 18 and 85 years old.I currently have cancer.You have metal in your head or implanted brain devices.I have had brain surgery.I recently started taking medication for epilepsy.You have attempted suicide in the past or have a history of suicidal behavior.
Research Study Groups:
This trial has the following groups:- Group 1: Sham (tDCS) + Sham TUS
- Group 2: Active (tDCS) + Active TUS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 10 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 24 Weeks after you stop receiving the treatment.
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT04379115 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment currently open for this investigation?
"Clinicaltrials.gov outlines that this trial is currently in the patient recruitment stage, with its posting date of July 18th 2020 and most recent review conducted on December 21st 2021."
Answered by AI
How many participants are partaking in this research study?
"Affirmative. Clinicaltrials.gov has verified that the trial, posted on July 18th 2020 and last modified December 21 2021, is actively enrolling 26 participants from two locations."
Answered by AI
Would I be eligible to partake in this research trial?
"This scientific investigation is enrolling 26 adults aged 18-85 with chronic pain. To qualify, individuals must have had OUD for at least 6 months (as defined by DSM-5), sign a consent form, be taking no more than 60mg of methadone/day from the Methadone program and not plan to relocate in the near future."
Answered by AI
Are elderly individuals aged 75 and older precluded from participating in the study?
"To be eligible for this medical experiment, participants must be between 18 and 85 years old. Simultaneously, there are 51 clinical trials designed specifically for minors and 570 studies aimed at seniors."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Ohio
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Illinois Health/ University of Illinois at Chicago
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I have only found suboxone that works and now thats not working anymore. I've tried all the pain meds and Subutex and I'm still in immense pain.
PatientReceived 1 prior treatment
I'm miserable. In pain all the time. Miserable from being on methadone that doesn't work so I misuse it. I just want freedom.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How often are visits to the study location, and how long are those visits on average?
PatientReceived 2+ prior treatments
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